BetrnetRF: Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01568723

Collaborator

National Cancer Institute (NCI) (NIH)

125

Enrollment

Locations

79.5

Duration (Months)

62.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Genetic: response to therapy

Detailed Description

This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue at risk for neoplastic progression as well as of response to ablation therapy. These results will result in improved risk stratification in BE and better targeting of resources for patients who are candidates for ablative therapy, while simultaneously providing key information regarding the origins of Barrett's esophagus.

Study Design

Study Type:

Observational

Actual Enrollment :

125 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Stem Cells And The Origins Of Barrett's Esophagus:Identification Of Novel Biomarkers And Gene Signatures In Barrett's Esophagus

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Aug 16, 2018

Actual Study Completion Date :

Aug 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Radiofrequency ablation participants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA)	Genetic: response to therapy evaluate specific markers for response to therapy at specific intervals pre and post therapy

Arm

Intervention/Treatment

Radiofrequency ablation

participants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA)

Genetic: response to therapy

evaluate specific markers for response to therapy at specific intervals pre and post therapy

Outcome Measures

Primary Outcome Measures

Response to therapy [one year post ablation]
evaulation will be made at 3 month intervals for one year post ablation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Barrett's esophagus with high grade dysplasia or intramucosal (early) adenocarcinoma.
BE length ≥ 2 cm and ≤ 8 cm.
Able to return every 3 months for one year after ablation

Exclusion Criteria:

Patients who are unable to be compliant with follow-up endoscopies
patients who cannot tolerate Proton Pump inhibitors
pre-existing esophageal strictures
pregnant or nursing women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University	New York	New York	United States	10032
2	University of Pennsylvania Perelman School of Medicine	Philadelphia	Pennsylvania	United States	19104-4311